• 2020-bl-COVID-19-food-safety-culture_132x132

    ISO 9001 in the Time of COVID-19

    Companies that were prepared with good quality management have fared better during the pandemic. ISO 9001 in particular has proved inadvertently helpful in adapting to disruption. To see how ISO connects to COVID-19, we spoke to Debby Newslow of D.L. Newslow & Associates.

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  • 2019-bl-thumb-humans-and-robots-on-the-factory-floor

    Industry 5.0: Top 3 Things You Need to Know

    Whether you like it or not, you should brace yourself for Industry 5.0. The term refers to people working alongside robots and smart machines. If that definition brought to mind the image of Will Smith battling evil robots in the movie “I, Robot,” here are a few things you need to know about Industry 5.0.

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  • 2020-bl-covid-19-flexible-scalable-manufacturing-thumbnail

    COVID-19 Highlights Need for Flexible, Paperless Manufacturing Processes

    The pandemic has highlighted the need for a faster, more flexible and scalable manufacturing environment that balances speed with compliance. While paper-based processes can slow production down or jeopardize quality, paperless production processes can streamline operations, reduce errors and readily leverage data critical to ensuring quality. A configurable, purpose-built electronic device history record (eDHR) application can be fast to implement and deliver quantifiable benefits.

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  • 2019-bl-thumb-measurable-benefits-paperless-manufacturing

    3 Quality Metrics Improved By Paperless Manufacturing

    A digital gap remains between quality assurance and manufacturing operations, as people on the production line still rely on paper-based production records and spreadsheets. This gap has left manufacturers susceptible to data entry errors, long good quality review times, shipment delays and other paper-based challenges. A paperless approach can deliver measurable results that have a notable impact on manufacturing operations, product quality and the bottom line.

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  • city-technology-nightscape-132

    Avoiding a Time Traveler’s Mindset With Effectiveness Checks

    How many times have you done something and immediately wished you could undo it? Or how many times have you wished you knew the outcome of something beforehand? Since time travel still eludes us, the best we can hope for is to try to fix our mistakes and anticipate future ones. In the regulated industry this is called corrective and preventive action (CAPA).

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  • 2020-bl-digital-tools-enhance-supplier-management-capability_132x32

    Digital Tools to Streamline Supplier Management Processes

    The global COVID-19 pandemic has forced many manufacturers to re-examine how they manage their supply chains. Amid large-scale shocks to supply and demand, manufacturers and their supplier partners must balance speed with quality, without putting their own employees at risk or adding significant costs. Now is the time to. Leveraging digital supplier management tools can help manufacturers streamline supplier processes like audits and inspections without the on-site threat to employees and vendors and unnecessary travel costs.

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  • 2020-bl-helpful-quality-event-mgmt-tips_132x132

    5 Helpful Quality Event Management Tips From a CAPA Pro

    Expert consultant, Ken Peterson, offers best practices for quality event management systems (QMS) that will help you avoid “death by CAPA.”

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    SPC vs SQC: The Strategic Difference

    The tension between after-the-fact inspection and defect prevention has been at the heart of manufacture since the introduction of statistical methods to industry in the 1940s. Today, to clearly divide responsibilities within an organization, and tie these very different activities to existing roles, consider a division by impact to the patient. Activities which monitor a process in real-time to prevent defects while a lot is being manufactured are known as Statistical Process Controls (SPC).

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  • 2020-bl-therapeutic-goods-admin-guidance_132x132

    Software as a Medical Device – Upcoming Changes to the Australian Regulations

    So much can change over a nearly 20 year period. Since the Australian Regulatory Framework for medical devices was adopted in 2002, the use and accessibility of software in medical applications has advanced beyond expectation.

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  • 2019-bl-thumb-digital-transform-your-supply-chain

    Our Expert Weighs in on Platforms, Data and AI

    MasterControl Product Management Director Sue Marchant sat down with GxP Lifeline to talk about our platform approach, why that’s important and how it can eventually lead to artificial intelligence (AI) applications for our customers. She also gave us a sneak peek at what to expect in the next generation of MasterControl products.

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  • 2020-bl-nelson-labs-respirator_132x132

    Nelson Labs on Adaptability and Communication in the Time of COVID-19

    Nelson Laboratories, a global provider of microbiological and analytical laboratory testing, is one of the many companies making an impact in the protective barriers area during the pandemic. The Salt Lake City-based company is heavily involved in testing the efficacy of facemasks and respirators. In a recent interview, Nelson Labs President Jeffrey R. Nelson spoke on what it has taken to achieve 24/7 coverage while maintaining quality and protecting employee health.

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    Mind the Gap! The 3 Biggest Gaps Faced When Implementing IVDR

    If you are preparing to implement IVDR, there are specific gaps that are easily missed. Ensure the intended purpose is clear, risk management issues have been addressed, and pay close attention to details.

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  • 2020-bl-4-reasons-document-review-critical_132x132

    Four 2019 Manufacturing Batch Record Trends Holding Up in 2020

    Manufacturing batch record trends from 2019 have picked up speed in 2020. Now is the time to focus on becoming data-centric, move to digital batch records, utilize the potential of workers on the shop floor, and create a truly paperless manufacturing environment.

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  • 2020-bl-cannabis-trend-brief_132x132

    Global 2020 Cannabis Trends

    Cannabis is legally and socially becoming more accepted worldwide. New regulations, new products and new technology are all helping the cannabis industry mature. In 2020, these trends are expected to shape the industry.

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  • 2020-bl-neutraceutical-trends_132x132

    2019 Nutraceutical Trends: Relevant During COVID-19

    Five major trends hit nutraceuticals last year. For the most part, those trends played out as expected. What was not expected was for the year to end in the COVID-19 pandemic. We’d like to take a look at how the pandemic has changed last year’s trends and what the future likely holds for the nutraceutical industry.

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  • 2020-bl-thumb-align-quality-across-ecosystem_132x132

    How to Align Quality Across an Expanding Ecosystem

    As companies grow more reliant on geographically dispersed contractors, partners, vendors and business units, it gets harder to align quality across all the entities involved. Learn how global companies like Fagron maintain quality consistency across multiple sites and discover why connecting data and processes within a robust digital platform is the surest way to align quality across your entire ecosystem.

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  • 2020-bl-thumb-remote-audits_312x132

    Remote Audits Reignite Regulated Companies and Supply Chains

    The COVID-19 pandemic disrupted many aspects of global societies, lifestyles and economies. Fortunately, technology has enabled the regulatory industry to continue functioning by conducting audits remotely. In this article, Derek Churchill, senior consultant at Quality Support Group (QSG), explains how remote audits work and how companies can prepare for this new type of audit.

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  • 2020-bl-thumb-quality-culture-data-integrity_132x132

    Having a Good Quality Culture Improves Your Data Integrity

    Data integrity is a high priority to both the pharmaceutical industry and regulatory authorities. To improve data integrity, it's critical to example the role of quality in your company culture.

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    Chronicles of a Document Control System

    Regulated companies are often reminded that if it isn’t documented, it didn’t happen. It’s also safe to say if it is documented, but the documents can’t be found, it didn’t happen. An efficient document control system is at the core of quality management and good manufacturing practices.

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  • 2020-bl-thumb-design-control-process_132x132

    What Verification and Validation Activities are Required for a First in Human Study?

    Manufacturers preparing for a first in human (FIH) study of a new medical device face questions. Learn answers about what verification and validation activities are required for a FIH study.

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